Who needs a controlled substances registration?

Any person, business, or entity in Missouri that wants to conduct any activities with controlled substances must have a registration. Examples would be purchasing, stocking, prescribing, administering, dispensing, manufacturing, distributing, and conducting research, or any other type of activity with controlled substances.

What authority do I have with or without a registration?

In order to have authority with controlled substances a person must have authority under the statutes of Missouri and the federal government. A person must have statutory authority or a professional license if required, then they must have a state registration from our bureau, and then finally a federal registration from the United States Drug Enforcement Administration. Long term care facilities are not required to have a DEA number for their emergency kits.

How many registrations do I need?

Most practitioners have one registration at their primary Missouri practice location where patient care occurs and controlled substance activities take place. Although they have one primary registered location, they may travel and prescribe at other places. A separate registration is required at each separate location where controlled substances are stocked and stored. Multiple registrations are required if a practitioner stocks controlled substances in multiple locations.

Separate registrations may be needed for separate activities. The primary registration will allow a practitioner to purchase, stock, dispense, prescribe and administer. Separate registrations are required to perform research, import, export, manufacture or distribute.

How do I get a Missouri Controlled Substances Registration?

A person may apply either in writing or electronically online. Under our link to applications and forms a person may print a paper application that may be mailed to the department. A person may also click a link to apply online electronically and click-to-pay with a credit card.

How long does it take to get a registration?

The amount of time depends upon the amount of workload arriving at the bureau daily and whether the applications are submitted complete and error free. Applications are processed in the same order that they arrive. Applications are processed and issued daily. The registration system is backed up and published on our website every night. Errors on the application require correspondence and delay the process. Applicants with discipline histories or who maybe undergoing current discipline may take longer to process. Most applications are processed and issued within the same week that they arrive.

How do I get my registration certificate?

Once registrations are issued the name of the registrant is placed into the registry. A person may verify and print a registration from the bureau’s website by searching under their name.

What can cause my registration to terminate?

Pursuant to law, the following situations cause a registration to terminate:

The registration expires;

The registrant dies;

The registrant goes out of business or has loss of their professional license;

A change in ownership of a business;

If the registrant moves or changes address from what is printed on their certificate and the registrant does not notify the bureau and received an updated registration within 30 days. If the change in address is not updated in 30 days then the prior registration automatically terminates on the 31st day after the change in address.

A registrant may write the bureau and voluntary close their registration.

What is the bureau’s authority and jurisdiction?

The bureau’s authority is to regulate controlled substance activities only. The bureau does not have authority regarding non-controlled drugs. The bureau’s authority is limited to controlled substances security and record keeping. The bureau does not have authority in areas regarding clinical issues or complaints regarding over-prescribing or under-prescribing. Complaints regarding practice issues are forwarded to the appropriate licensing board.

Who has authority to inspect my controlled substances and records?

Pursuant to Section 195.375.5, RSMo, prescriptions, orders, and records, required by sections 195.005 to 195.425, and stocks of controlled substances shall be open for inspection only to federal, state, county, and municipal officers, whose duty it is to enforce the laws of this state or of the United States relating to narcotic drugs.

Law enforcement officers and regulatory investigators are held to the same level of confidentiality that the practitioners are. Registrants who release records to the BNDD as required by state law, are given immunity from civil liability.

What are the most common violations by registrants?

The most common violations are issues regarding controlled substance record keeping. Common record’s violations are failure to conduct annual inventories correctly, failure to maintain and document purchasing and receipt records and failing to correctly document dispensing logs. Having a registration terminate for failing to notify the bureau of an address change is common.

Other types of violations regarding security and safety of the public are violations such as failing to provide adequate security for controlled substances, stealing drugs, self-administering, impairment, falsifying records and issuing prescriptions in bad faith.

How do I handle a change of name or address?

A registrant may update their registration by changing their name, address or drug schedules. The requests should be submitted in writing to the bureau and the requests will be processed as allowed for no fee. Requests can be submitted electronically through the bureau’s registration process or requests can be faxed or emailed to the bureau. All changes must be signed, submitted and approved by the registrant.

How do I handle a change of ownership in my business?

A change in ownership requires a new registration by the new controlling part. The bureau considers the ownership to change whenever a majority or over 50% of the stocks or assets have changed hands. There is a grace period where the new owner may operate under the seller’s registration. The seller must grant their permission and the grace period is for 30 days, beginning at the date of sale/closing. By the 31st day the new owner must have their own registration.

How do I handle a loss of controlled substances?

The bureau’s state regulations are different than the federal DEA regulations.
All losses, thefts and diversions must be reported to the bureau immediately upon discovery. A loss report form must be submitted to the bureau within 7 days of discovering the loss. If more time is needed the registrant may contact the bureau and ask for more time.

A drug is considered “lost” if it is missing and the registrant does not know where it went or what happened to it.

Insignificant losses are those instances where lawful activity was taking place and something happened to make the drug un-recoverable. A tablet was stepped on and crushed, a bottle was spilled, or a container leaked. In these cases there was no theft and the registrant knows what happened to the drugs. These instances are documented on paper and stapled to the annual inventory, but no loss form is required to the bureau. This is detailed in regulation 19 CSR 30-1.034. A loss report form is available on the bureau’s link to forms on our website.

What types of discipline do violations bring?

Discipline varies on the number and severity of violations, the threat to the public’s health and safety, and previous actions or issues with the registrant. According to Section 195.040, RSMo, depending upon the nature and magnitude of the violations identified, the bureau may pursue any of the following:

Non-Public Actions—Confidential and not shared with the public or reported to a national database:

Issue a Letter of Warning

Issue a Letter of Censure

Public Actions that may be shared with the public and reported to a national database:

Denial of an application for a registration;

Registration placed on probation with certain terms and conditions;

Suspension of a registration;

Revocation of a registration

The bureau is only authorized to pick one type of discipline and cannot combine two types.